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Evaluation of a Molecular Test for the rapid detection of of microorganisms in patients with Generalized Infection (Sepsis)

Evaluation of a Molecular Method for the rapid detection of pathogens in patients with Sepsis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-4vt6th
Enrollment
Unknown
Registered
2018-04-30
Start date
2018-05-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Interventions

Objective: To compare the detection of microorganisms among molecular and traditional methods in patients with suspected sepsis
Population: Inclusion of 300 patients with clinical suspicion of sepsis hospitalized in the ICU during the period of 1 year. Procedure: Collection of 2 blood cultures samples (microbiology), plus 5
Other
E01.370.225.998.110

Sponsors

Fundação Oswaldo Cruz
Lead Sponsor
Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with suspicion of sepsis that required hospitalization in an intensive care unit

Exclusion criteria

Exclusion criteria: Pregnant patients; Patients younger than 18 years. Dying patients, in palliative care or with an expectation of ICU stay less than 24 hours.

Design outcomes

Primary

MeasureTime frame
Accuracy of the molecular testing for etiological diagnosis in blood samples from patients with clinical suspicion of sepsis in comparison with the standard method.—

Secondary

MeasureTime frame
Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value in comparison with the standard method.—

Countries

Brazil

Contacts

Public ContactFernando Bozza

Fundação Oswaldo Cruz

bozza.fernando@gmail.com+55(21)993031551

Outcome results

None listed

Source: REBEC (via WHO ICTRP)